REDUCE Trial: A randomised controlled trial evaluating the efficacy of indwelling pleural catheters in persistent non-malignant symptomatic pleural effusions

Not Applicable

Completed

• Conditions: Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory; Respiratory

• Registration Number: ISRCTN66354436
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34413152/ (added 07/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-15
• Study Completion: 2017-08-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Clinically confident diagnosis of non-malignant pleural effusion secondary to either advanced stage CHF or liver failure requiring and amenable to pleural intervention for relief of breathlessness
2. Assessment by a cardiologist or hepatologist determining the presence of established heart failure or liver failure and a pleural effusion that persists despite optimised medical therapy
3. At least one previous therapeutic aspiration of pleural fluid with results consistent with the cause of the effusion being due to CHF or liver failure either:
3.1. a transudate by Light’s criteria in cases of effusions due to liver failure OR
3.2. either a transudate in effusions due to CHF or an exudate in cases where diuretics have been used and CHF can confidently be stated to be the cause
4. No evidence of malignancy on pleural fluid cytology
5. Expected survival >12 weeks
6. Written informed consent to trial participation
7. Target Gender: Male & Female
8. Lower Age Limit 18 years

Exclusion Criteria

1. Age <18 years
2. Known pleural malignancy
3. Pleural fluid pH < 7.2
4. Previously sited indwelling pleural catheter on the side requiring intervention or current indwelling pleural catheter on the contralateral side
5. Pregnancy, lactation or intention to become pregnant
6. Inability to give informed consent
7. Absolute contraindication to IPC or therapeutic aspiration of pleural fluid
8. Patient has no access to a telephone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in breathlessness (VAS score); Timepoint(s): Change to VAS over 12 week trial period

Secondary Outcome Measures

Name	Time	Method
<br> 1. Adverse events related to trial intervention; Timepoint(s): 12 weeks<br> 2. Albumin levels in patients with liver disease; Timepoint(s): 12 weeks<br> 3. Cost effectiveness; Timepoint(s): 12 weeks<br> 4. Failure of initially randomised treatment; Timepoint(s): 12 weeks<br> 5. Health related quality of life (EQ-5D); Timepoint(s): 12 weeks<br> 6. Hospital visits and bed days; Timepoint(s): 12 weeks<br> 7. Number of pleural interventions; Timepoint(s): 12 weeks<br> 8. Pleurodesis; Timepoint(s): 12 weeks; Volume of fluid drained; Timepoint(s): 12 weeks<br> 9. Volume of fluid drained; Timepoint(s): 12 weeks<br>